Immuno-Oncology / Checkpoint

Summit Therapeutics has signed a clinical collaboration with AstraZeneca and its Japan-based partner Daiichi Sankyo to evaluate ivonescimab in combination with the antibody-drug conjugate Datroway, also known as datopotamab deruxtecan, across multiple solid tumors including breast and lung cancers. The collaboration is expected to initially focus on a phase III study in first-line triple-negative breast cancer, expanding ivonescimab's development into a new tumor type. Under the agreement, each company will supply its respective drug, AstraZeneca or Daiichi will sponsor the planned studies, and the companies will share study costs while retaining development and commercial rights to their own therapies. The Datroway collaboration builds on the larger deal between AstraZeneca and Summit announced in the last week, under which AstraZeneca agreed to invest $2 billion in Summit to accelerate development of ivonescimab, with the companies also set to evaluate ivonescimab alongside AstraZeneca's investigational Claudin-18.2-targeted ADC sonesitatug vedotin, or Sone-Ve, in gastrointestinal cancers. An FDA filing is under review seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment, with a final decision expected by Nov. 14, 2026.

Summit Therapeutics announced the closing of AstraZeneca's $2.0 billion strategic equity investment in the company. Under the Securities Purchase Agreement, AstraZeneca purchased approximately 108,955 shares of preferred stock convertible into Summit common stock at a 1:1,000 ratio, representing a common stock price of $18.36, a premium over the closing trading price on the day the investment was announced. The proceeds will support accelerated development of ivonescimab, a potential first-in-class investigational PD-1 / VEGF bispecific antibody, across solid tumor settings including combinations with antibody drug conjugates such as sonesitatug vedotin and Datroway. Summit Chairman and Co-Chief Executive Officer Robert W. Duggan said the investment reflects AstraZeneca's confidence in Summit and in ivonescimab's potential to redefine cancer treatment. Baker Hostetler LLP is serving as legal advisor to Summit.

Agenus Inc. announced three-year follow-up results from the ovarian cancer cohort of its 400+ patient Phase 1b C-800-01 trial, showing an estimated 48% three-year overall survival for botensilimab plus balstilimab in recurrent ovarian cancer. The estimate was unchanged from two years, with median overall survival of 14.8 months, a 23% objective response rate among 35 evaluable patients, and a median duration of response of 9.7 months. At last follow-up, 25% of the 44 patients who received at least one dose, 11 in total, were alive and off all therapy. The heavily pretreated population had received a median of four prior lines of therapy, 77% had received bevacizumab and 57% a PARP inhibitor, and nearly three-quarters had platinum-resistant or refractory disease; estimated three-year survival was 47% in that subgroup and 61% in the 17 patients whose disease had progressed on a PARP inhibitor. The data were presented by Rebecca L. Porter of Dana-Farber Cancer Institute at the 2026 International Gynecologic Cancer Society Annual Global Meeting in Montréal, and Agenus said no new safety signals or treatment-related deaths were reported.

Yuanta Securities issued an analysis turning more bullish on SINOBIO19, or the ordinary shares of SINO BIOPHARMACEUTICAL LIMITED (1177.HK), after the company announced a partnership with STADA, a global pharmaceutical company in Germany, to bring TQB3570, a biologic drug with efficacy close to that of Keytruda, the world's most popular cancer treatment, into the European, UK, and Swiss markets, with the potential to expand into the US market in the future. Under the deal, Sino Bio will manufacture and supply the drug itself but distribute it under STADA's brand, and will recognize a profit share of more than 10%. This means Sino Bio will recognize revenue from both manufacturing and an additional share of profits when STADA sells the drug in the region, creating a new revenue base for the company. Meanwhile, the Chinese government continues to target innovative pharmaceuticals as one of its key industries and will push for the sector to grow by an average of 20% per year during 2026-2030, giving the company the opportunity to receive government support both in speeding up approvals for drugs in its pipeline and in supporting R&D. As for this year's normalized profit outlook, the Bloomberg Consensus expects normalized profit to continue growing by 5%. The current price trades at a 2027 PER of 18 times. It gives a target price of 7.10 baht per DR, implying 44% upside.

AstraZeneca said the FDA has granted Priority Review to a supplemental Biologics License Application for IMFINZI with enfortumab vedotin in muscle-invasive bladder cancer. The application targets patients who are ineligible for or decline cisplatin-based chemotherapy, a group with limited treatment choices. Priority Review shortens the FDA review timeline for this regimen, reflecting the agency's view that it may offer a meaningful clinical advance. AstraZeneca, a £192.8 billion pharmaceuticals group focused on prescription medicines, has been building its oncology presence across several tumour types, so any potential label expansion for IMFINZI touches a core therapy area rather than a side project for the business.

On September 29, Summit announced that AstraZeneca will make a strategic equity investment of $2 billion in the company and will take the lead in advancing clinical research on ivonescimab combined with AstraZeneca's Sonesitatug Vedotin for the treatment of multiple gastrointestinal tumors. The two parties also plan to further promote clinical exploration of combination therapies involving ivonescimab and a range of AstraZeneca antibody-drug conjugates and other anti-tumor drugs. Boosted by this news, innovative drug concept stocks were repeatedly active in early trading on September 30. CanSino Biologics hit the 20-cent daily limit up, Berry Genomics hit the daily limit up, and Sino Biological, Tri-Prime Gene, and Walvax Biotechnology quickly followed with gains. On the same day, China's three major A-share indices opened collectively higher. As of press time, the Shanghai Composite Index rose 0.35 percent, the Shenzhen Component Index rose 0.48 percent, the ChiNext Index rose 0.92 percent, and the SSE STAR 50 Composite Index rose 0.31 percent. By sector, biotechnology, power generation equipment, and gas were relatively active, while the real estate sector led declines, and internet, semiconductor, and software sectors fluctuated in adjustment.

AstraZeneca agreed to make a $2 billion strategic equity investment in Summit Therapeutics, sending the biopharmaceutical company's shares up 17.1% in premarket trading. The investment supports a collaboration combining Summit's flagship bispecific antibody, ivonescimab, with AstraZeneca's oncology pipeline, and AstraZeneca will acquire convertible preferred shares at a price equivalent to $18.36 per common share, a 10% premium to Summit's five-day volume-weighted average price. Fair Isaac tumbled 15% after the Federal Housing Finance Agency announced changes to mortgage pricing that will introduce competition to FICO's longstanding role in the mortgage credit-scoring market; FHFA Director Bill Pulte said Fannie Mae and Freddie Mac will consolidate their separate pricing matrices into a single unified grid that will incorporate VantageScore alongside the traditional FICO Classic score. CarMax rose 3.7% after reporting fiscal second-quarter earnings of $1.16 per share, beating analyst expectations of 68 cents, with revenue of $7.88 billion topping forecasts of about $7.06 billion. AAR Corp. surged 6.9% after announcing an agreement to acquire a 65% controlling interest in MRO Holdings at an implied enterprise value of $4 billion, alongside adjusted diluted EPS of $1.49 and revenue of $918 million that beat expectations. Netflix rose 1.4% after Deutsche Bank upgraded the streaming giant to Buy from Hold with a $95 price target, while AbCellera Biologics gained 2.1% on a JPMorgan Overweight initiation with a $17 price target and Q32 Bio rose 9.4% ahead of a key clinical data presentation at the European Academy of Dermatology and Venereology Congress in Vienna beginning Sept. 30.

China's innovative drug industry has welcomed another major licensing deal. Shanghai Sprout and Merck jointly announced a global exclusive licensing agreement for SPR2015, a preclinical oral KRAS G12D (ON) inhibitor, with a potential total value of $2.13 billion, including an upfront payment of $400 million, with the remainder tied to development and commercialization milestones. Meanwhile, Summit Therapeutics, the overseas partner of Akeso, announced that AstraZeneca will make a $2 billion strategic equity investment in Summit and intends to lead clinical exploration of Akeso's first-in-class tumor immunotherapy 2.0 cornerstone drug ivonescimab in combination with AstraZeneca's Sonesitatug Vedotin for treating multiple gastrointestinal tumors. The two parties also signed a memorandum of understanding to further advance clinical exploration of ivonescimab combined with a range of AstraZeneca antibody-drug conjugates and other anti-tumor drugs. Boosted by the news, as of 10:01 a.m. on September 29, 2026, the STAR Market Biotech ETF managed by Penghua Fund, with ticker 588250, saw its underlying index, the SSE STAR Market Biomedical Index with code 000683, rise 1.10%. Among constituents, InventisBio rose 5.16%, Micro-Tech Nanjing rose 3.84%, Hotgen Biotech rose 3.13%, and Huiyu Pharmaceutical and Yound Biotechnology followed the gains. China Securities pointed out that the medical device sector has reached an inflection point in 2026, and stocks with improving performance are expected to see dual recovery in valuation and earnings. High-value consumables and in-vitro diagnostics segments are expected to gradually clear the impact of centralized procurement price cuts in the second half of the year, and leaders in niche tracks will accelerate growth.

AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration for ORPATHYS, or savolitinib, plus TAGRISSO, or osimertinib, for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification and who progressed on or after an EGFR tyrosine kinase inhibitor therapy, HUTCHMED announced. The filing is supported by the global SAFFRON Phase III trial, the first global Phase III trial to demonstrate statistically significant and clinically meaningful improvements in progression-free survival and overall survival in this setting, versus doublet platinum-based chemotherapy in patients who progressed on TAGRISSO. SAFFRON enrolled 338 patients across 230 centers in 29 countries and builds on evidence from the SACHI Phase III and SAVANNAH Phase II trials, with results to be presented in a Presidential Symposium at the upcoming European Society for Medical Oncology Congress 2026. ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca; the combination is already approved in China based on SACHI and received a temporary authorization in Switzerland based on SAVANNAH. Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said the filing is an important step toward potentially bringing the biomarker-directed, chemotherapy-free oral combination to patients in the US.

Merck announced that the FDA has expanded the label of its oral cancer drug Welireg, also known as belzutifan, for a third indication in advanced renal cell carcinoma, the most common type of adult kidney cancer. The drug is now approved in combination with Eisai's Lenvima, or lenvatinib, to treat adult patients with advanced renal cell carcinoma with a clear cell component following a PD-1/PD-L1 inhibitor. The approval is supported by data from the phase III LITESPARK-011 study, which evaluated the combination against Exelixis' Cabometyx, or cabozantinib, and met one of its dual primary endpoints of progression-free survival, reducing the risk of disease progression or death by 26 percent, though it did not meet the other primary endpoint of overall survival and showed only a trend toward improvement. The new indication could further expand Welireg's addressable patient population in advanced clear cell renal cell carcinoma, and it gives Merck another treatment option in a market where Cabometyx is established. Welireg sales reached 470 million dollars in the first half of 2026, up 57 percent year over year, and the drug is already approved for two other clear cell renal cell carcinoma indications as well as for von Hippel-Lindau disease and for pheochromocytoma or paraganglioma in patients aged 12 years and older.

Innovent Biologics announced the expansion of the global Phase 3 MarsLight-11 trial of IBI363, also known as TAK-928, to include patients with non-squamous non-small cell lung cancer. The trial previously evaluated the therapy only in patients with squamous NSCLC whose disease had progressed on or after chemotherapy and immunotherapy. The non-squamous evaluation will run as a new substudy, so MarsLight-11 will now comprise two independent substudies, one in squamous NSCLC and one in non-squamous NSCLC, each testing IBI363 monotherapy against docetaxel in unresectable, locally advanced or metastatic disease that has progressed during or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein co-developed globally by Innovent and Takeda, and it has received two Fast Track Designations from the U.S. FDA and three Breakthrough Therapy Designations from China NMPA. In October 2025 the two companies signed a license and collaboration agreement covering global co-development and U.S. co-commercialization, with Takeda holding exclusive commercialization rights worldwide outside the U.S. and greater China.

Moderna and Merck reported that their Phase 3 INTerpath-001 trial of personalized cancer vaccine intismeran autogene plus Keytruda met its primary endpoint in melanoma, with full data presented earlier this month at the European Society for Medical Oncology Congress 2026. Moderna is also in talks with Middle East partners about potential investment and manufacturing cooperation, pairing its mRNA oncology push with efforts to extend its geographic footprint and industrial capabilities beyond its original COVID-19 franchise. The company recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, underscoring its push to build a non-seasonal respiratory portfolio. Moderna's narrative projects $4.5 billion revenue and $782.2 million earnings by 2029, yielding a $119.56 fair value, a 40% downside to its current price, while some of the most optimistic analysts assume revenue could reach about US$8.5 billion and earnings turn positive by 2029.

Pfizer Canada and BioNTech announced Health Canada's approval of the Omicron XFG-adapted COMIRNATY vaccine for individuals aged 6 months and older, aligning with 2026-2027 public health recommendations. A few days earlier, BioNTech and OncoC4 reported that the investigational CTLA-4 antibody gotistobart nearly doubled median overall survival versus chemotherapy in a Phase 3 lung cancer trial stage. The Health Canada authorization, following earlier US and EU XFG approvals in 2026, shows the COVID-19 franchise still contributes regulated, seasonal revenue while BioNTech leans into oncology. BioNTech's narrative projects €2.2 billion revenue and €390.1 million earnings by 2029, implying a 6.0% yearly revenue decline and an earnings increase of about €2.1 billion from -€1.7 billion today, with a $118.06 fair value and 20% upside to its current price. Bullish analysts assume revenue climbs to about €3.0 billion and earnings to €313.1 million by 2029, though the new gotistobart data and oncology execution risks could shift how those upbeat assumptions are weighed against more cautious views.

Inhibrx Biosciences said its experimental cancer drug INBRX-106 combined with Merck's Keytruda produced a confirmed objective response rate of 48.3% versus 26.5% for Keytruda alone in the Phase 2 portion of its HexAgon study in treatment-naive, PD-L1-positive metastatic or unresectable recurrent head and neck squamous cell carcinoma. The study enrolled 68 patients, with 63 evaluable for the primary endpoint, and four patients, or 13.8%, on the combination achieved a complete response versus none on Keytruda alone. Median progression-free survival was 9.6 months for the combination versus 4.9 months for Keytruda alone as of the August 19 data cutoff, and among 10 evaluable HPV-positive patients the confirmed response rate was 80% versus 33.3% among nine patients on Keytruda alone. Inhibrx plans to add approximately 50 HPV-positive oropharyngeal cancer patients to the Phase 2 study to support a potential accelerated regulatory pathway, estimating the U.S. could have approximately 30,000 HPV-positive head and neck cancer patients by 2029, including around 6,000 first-line recurrent patients, representing a $1 billion annual sales opportunity. Despite the data, Inhibrx shares fell 8.8% to $110.45, a move CEO Mark Lappe told Reuters the company could not explain, while Stifel analyst Dara Azar called the results competitive against the difficult OX40 target.

Bristol Myers Squibb's growth portfolio now accounts for 56% of total revenues, up from 51.8% a year earlier, after sales from those products rose 13% in the first half of 2026. The growth portfolio comprises Opdivo, Opdivo Qvantig, Orencia, Yervoy, Reblozyl, Camzyos, Breyanzi, Opdualag, Zeposia, Sotyktu, Krazati and Cobenfy, while legacy products including Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane make up the remaining 44% of revenues and face loss of exclusivity and generic competition. Opdivo Qvantig, the subcutaneous formulation of Opdivo, is now generating more than $1 billion in annualized revenues, and the FDA recently granted accelerated approval to iberdomide, in combination with daratumumab and hyaluronidase-fihj and dexamethasone under the brand name Zenbexus, for adults with multiple myeloma who have received at least one prior line of therapy, making it the first FDA-approved cereblon E3 ligase modulator. The Zacks Consensus Estimate for 2026 EPS has moved north to $6.91 from $6.34 in the past 60 days, while the 2027 EPS estimate has improved to $6.46 from $6.12. Bristol Myers shares have gained 13.4% year to date compared with the industry's growth of 8.5%, and the stock trades at 9.28X forward earnings versus the large-cap pharma industry's 18.23X.

AbbVie announced that Health Canada has issued a Notice of Compliance for EPKINLY, also known as epcoritamab, for a new follicular lymphoma indication in adults. The approval covers EPKINLY in combination with lenalidomide and rituximab for adult patients with relapsed or refractory Grade 1, 2, or 3a follicular lymphoma who have received at least one prior line of systemic therapy. The authorization is supported by results from the Phase 3 EPCORE FL-1 study, which included 488 adults with relapsed or refractory follicular lymphoma, in which adding EPKINLY to lenalidomide and rituximab reduced the risk of disease progression or death by 79% compared with lenalidomide and rituximab alone, with a hazard ratio of 0.21 and a 95% confidence interval of 0.13 to 0.33 and a p value below 0.0001. EPKINLY is a bispecific antibody administered by injection under the skin and is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma, accounting for approximately 20% to 25% of NHL diagnoses in Canada, with approximately 2,400 to 3,000 Canadians diagnosed each year.

Regeneron Pharmaceuticals executives told Bernstein analyst Jeffrey Walch that EYLEA HD, Dupixent and Libtayo each reached all-time quarterly net sales, with EYLEA HD accounting for roughly 60% of EYLEA franchise net sales in the second quarter. Chief financial officer Chris Fenimore said Regeneron expects sequential demand growth for EYLEA in the low- to mid-teens percentage range in both the third and fourth quarters despite additional biosimilar competition in the 2-milligram market, and that the company paid off its Sanofi development balance in the second quarter, a move expected to lift earnings from the Sanofi collaboration beginning in the third quarter. Dupixent is annualizing at approximately $24 billion in sales, including approximately $18 billion in the U.S., while Libtayo sales rose more than 30% year over year and now rank second in both new-to-brand and total share in U.S. lung cancer. On the pipeline, the FDA action date for cemdisiran in generalized myasthenia gravis is in November, registration-enabling PNH data are expected in the fourth quarter, and further readouts are anticipated in MASH, Factor XI and melanoma. Regeneron repurchased approximately $2 billion of stock in the first half, including $1.2 billion in the second quarter, and pays roughly $400 million annually under a dividend program begun in 2025.

Asia Plus Securities stated that the Government Pharmaceutical Organization, together with Chulalongkorn University and Seqker Biosciences, is developing a personalised cancer vaccine that uses patients' genetic data to stimulate the immune system to attack cancer cells specifically. The vaccine is currently in phase 3-4 clinical research and has begun use in two foreign patients, with plans to extend into Medical Visa services and expand to state hospitals. The goal is to reduce treatment costs from 4-7 million baht to around 1 million baht. The research team views the private hospital sector positively over the medium to long term, because personalised cancer vaccines tend to complement Precision Medicine and Immunotherapy rather than replace existing treatments, creating opportunities to increase revenue per patient throughout the cancer treatment process, from genetic testing and laboratories to treatment and follow-up. It assesses that BH and BDMS are the main beneficiaries, maintains an overweight stance on the hospital sector relative to the market, and keeps buy recommendations on BH and BDMS with 2027 fair values of 225.00 baht and 25.00 baht respectively.

Moderna will present detailed data from the phase III INTerpath-001 study of intismeran autogene, its personalized mRNA cancer therapy developed with Merck, at the European Society for Medical Oncology Congress next month. The findings will be presented on Oct. 24 in a Presidential Symposium, a session highlighting cutting-edge and potentially practice-changing clinical research, and are expected to provide investors with detailed data beyond the top-line results Moderna reported last month. Last month, Moderna and Merck reported positive results from INTerpath-001, which evaluated intismeran in combination with Merck's Keytruda in patients with high-risk Stage IIB-IV melanoma whose tumors had been surgically removed; the study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, though the companies did not report numerical data, stating only that the improvements were statistically significant and clinically meaningful. The companies are advancing intismeran across nine phase II and phase III studies spanning multiple tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, and a commercial launch of the therapy is targeted as early as next year. Moderna shares rose 12% yesterday, climbing to a new 52-week high of $176.86, and have skyrocketed nearly 500% year-to-date, significantly outperforming the industry's 6% growth.

Merck received Japanese approval for KEYTRUDA QLEX, also known as KEYJECT, its first subcutaneous formulation of KEYTRUDA, cleared for all existing local indications in the country. The new subcutaneous version offers an alternative to intravenous dosing and is aimed at faster administration for patients and clinicians. The approval broadens Merck's oncology treatment options in Japan, a key international market for its immunotherapy portfolio, and supports the view that the company can deepen the KEYTRUDA franchise rather than rely on a single route of administration. The article notes that convenience-driven launches do not directly address questions about pricing pressure, GARDASIL softness, or eventual KEYTRUDA loss of exclusivity that analysts have already flagged as risks. The balance still appears positive for the Merck narrative, but only if subcutaneous use contributes to the company's wider plan for more than 20 pipeline growth drivers.